Nektar Therapeutics released new data for its rezpegaldesleukin, following the accusations made against Eli Lilly over incorrect results in August.
Nektar reported new statistically significant results across three clinical efficacy endpoints from a Phase Ib trial in patients with atopic dermatitis (AD).
According to the new data release, patients treated with the 24µg/kg dose of rezpegaldesleukin achieved 72% mean improvement in affected Body Surface Area (BSA) from baseline at 12 weeks. Participants in the 12µg/kg dose group achieved 55%.
Participants treated with the high dose achieved 78% mean improvement in Dermatology Life Quality Index (DLQI) from baseline while the low dose cohort achieved 48%.
The treatment at the highest dose resulted in a mean Patient-Oriented Eczema Measure (POEM) improvement of 58% and the low dose showed a 44% improvement.
Upcoming Phase IIb trial
Alongside the new data release, Nektar announced plans for its upcoming Phase IIb trial with rezpegaldesleukin in biologic-naïve patients with moderate-to-severe AD. The trial is expected to start in October.
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According to a recent corporate presentation, 400 participants will be randomised into three dosing cohorts and one placebo arm in a 16-week induction period. After, patients will be randomised into six treatment arms and one placebo cohort for a 28-week maintenance period. Participants then will be followed up for ten weeks.
The primary endpoint of the trial will measure the mean percentage in the Eczema Area and Severity Index (EASI) score improvement at week 16.
Rezpegaldesleukin expansion into alopecia
Nektar also announced plans to initiate a Phase IIa trial with rezpegaldesleukin in alopecia areata. The trial is expected to start in early 2024.
According to the corporate presentation, the trial will enrol 42 patients with a 50 or more score in the Severity of Alopecia Tool (SALT). The enrolment of patients with a SALT score of 95-100 will be limited to 20 participants.
SALT, which is the trial’s primary endpoint, is a common assessment to measure the extent of scalp-hair loss.
The study will investigate the high dose of rezpegaldesleukin administered once every two weeks compared to placebo for 36 weeks. Participants will be followed up for 24 weeks.
Fall out with Lilly
Last month, Nektar stated that its former partner Eli Lilly published incorrect results from two trials in AD and psoriasis. The newly calculated data demonstrated rezpegaldesleukin’s improved efficacy in both indications.
The incorrect calculations were discovered after raw data files from the studies were transferred from Lilly to Nektar. According to Reuters‘s reporting at the time, Nektar is attempting to sue its former partner and has filed a complaint to the federal court in San Francisco, US.